Clinical Trial

Prostate Advances in Comparative Evidence

Study acronym: PACE

Active, Not Recruiting Phase 3

Record status

This record was last updated January 19, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Summary

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Protocol Amendment History 9 amendments

This ClinicalTrials.gov record has been amended 9 times since 2012-04-22; most recent amendment 2024-01-18.

Status change: Recruiting → Active, Not Recruiting 2024-01-18

Status change: Terminated → Recruiting 2015-02-20

Status change: Recruiting → Terminated 2014-06-23

Trial Details

NCT Number	NCT01584258
Lead Sponsor	Royal Marsden NHS Foundation Trust Collaborators: The Institute of Cancer Research, Sutton, Surrey, UK
Conditions	Prostate Cancer
Enrollment	2,205 participants
Start Date	2012-08-07
Primary Completion	2025-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2024-01-19